Exact FDA event identifier

Event 93975

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 12, 2024
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Micro Labs Limited

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01

D-0348-2024

Recall number: D-0348-2024
Initiated: February 12, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Micro Labs Limited
Quantity: 24,768 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Out of specification for residual solvents.

Code information

ZOAG043

Distribution pattern

Nationwide in the USA